The Effect of Milk Protein vs Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children

Growth Acceleration Clinical Trial

— PROGRO  

Official title:

The Effect of Milk Protein vs. Blends of Milk and Plant Protein on Growth Markers in 7-8 Year Old Healthy Danish Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03384719
• Other study ID #: D221
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: December 18, 2018

Study information

• Verified date: December 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of PROGRO is to determine which combinations of milk and plant proteins are optimal to promote growth factors in children

Description:

The main objective is to assess how different protein blends affect growth factors in children. There is evidence to support that milk protein increases growth in children in both high and low-income countries. Therefore milk protein is often used in food aid for undernourished children in low-income countries. The study investigates if plant protein can partially replace milk protein without affecting growth promotion negatively. Plant protein could potentially reduce food aid costs and at the same time be a more sustainable protein source.

The PROGRO study is a 3-arm randomized, controlled trial. The effect of consuming 35 g pure milk protein/day is compared to intake of 35 g milk and rapeseed protein/day (ratio 30:70 and 54:46, respectively) in 7-8 year old healthy Danish children. The intervention period is 4 weeks and measurements and blood sampling are performed at baseline, week 1 and week 4. A 3-day weighed dietary intake is recorded before each visit. The primary outcome is Insulin-like growth factor-1 (IGF-1).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 8 Years

Eligibility

Inclusion Criteria:

• Age 7-8 years

• Healthy*

• The child is willing to consume protein powder twice a day for 4 weeks

• The child is not a picky eater and so does not mind trying new foods and flavours

• The child speaks Danish in order to understand the study procedures

• The parents read and speak Danish in order to be properly informed about the study procedures

• Written informed consent has been obtained

• The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved

Exclusion Criteria:

• The child drinks more than 350 ml of milk per day

• Known or suspected allergy, sensitization or intolerance to milk (protein or lactose), rapeseed or mustard

• Any acute illness*

• Chronic illness or disease that may affect protein metabolism or growth*

• Chronic intake of medicine that may affect protein metabolism or growth*

• Concomitant participation in other studies involving dietary supplements or blood sampling

• Living in a household with another participating child

• The principal investigator, who is blinded to study treatment, will perform a case-by-case medical evaluation of children with any signs of being unhealthy or having any illness or taking medication at the time of admission. If the conditions are considered to potentially affect protein metabolism or growth, the children will not be included. If a child is acutely ill at the scheduled time of study start, the child cannot be included. But the child may be included later when the acute illness has resolved

Related Conditions & MeSH terms

• Growth Acceleration
• Growth Disorders
• Growth; Stunting, Nutritional

Intervention

Dietary Supplement:
• 35 g protein (30% milk + 70% rapeseed)
The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake. Protein powder ingredients (all are food quality): Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark) Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada) Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day.
• 35 g protein (54% milk + 46% rapeseed)
The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake. Protein powder ingredients (all are food quality): Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark) Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada) Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day.
• 35 g protein (100% milk)
The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake. Protein powder ingredients (all are food quality): Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark) Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day.

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods, University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Grenov B, Larnkjær A, Ritz C, Michaelsen KF, Damsgaard CT, Mølgaard C. The effect of milk and rapeseed protein on growth factors in 7-8 year-old healthy children - A randomized controlled trial. Growth Horm IGF Res. 2021 Jul 21;60-61:101418. doi: 10.1016/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in weight	The weight is measured once on a digital weighing scale (Tanita MC 780) in kg	from baseline to week 1 and week 4, respectively
Other	Change in body mass index (BMI)	BMI = weight divided by height squared (kg/m2). Weight is measured once using a digital weighing scale while the child is wearing underwear (Tanita MC 780, unit: kg) and height is measured three times to the nearest millimeter using a stadiometer (unit: meter).	from baseline to week 1 and week 4, respectively
Other	Change in waist circumference	Measured three times to the nearest millimeter using a non-elastic measuring tape	from baseline to week 1 and week 4, respectively
Other	Change in bio impedance	Tanita MC 780MA segmental multi frequency body composition analyzer	from baseline to week 1 and week 4, respectively
Other	Change in subscapular and triceps skinfolds	Subscapular and triceps skinfolds are measured three times to the non-dominant side to the nearest 0.2 millimeter using a Harpenden skinfold caliper while the child is standing	from baseline to week 1 and week 4, respectively
Other	Change in free amino acids in plasma	Blood sample	from baseline to week 1 and week 4, respectively
Other	Change in height	Height is measured three times to the nearest millimeter using a stadiometer	from baseline to week 1 and week 4, respectively
Other	Change in blood pressure	Blood pressure will be measured three times by an automated medical device while the child is lying down. Blood pressure is measured after 10 minutes rest	from baseline to week 1 and week 4, respectively
Other	Change in pulse rate	Blood pressure and pulse will be measured three times by an automated medical device while the child is lying down. Blood pressure and pulse are measured after 10 minutes rest	from baseline to week 1 and week 4, respectively
Other	Change in appetite hormones	Blood sample: leptin	from baseline to week 1 and week 4, respectively
Other	Change in appetite hormones	Blood sample: adiponectin	from baseline to week 1 and week 4, respectively
Other	Change in bone turnover marker: CTX (C-terminal telopeptide, carboxy-terminal collagen crosslinks)	Blood sample	from baseline to week 1 and week 4, respectively
Other	Change in bone specific alkaline phosphatase	Blood sample	from baseline to week 1 and week 4, respectively
Other	Change in osteocalcin	Blood sample	from baseline to week 1 and week 4, respectively
Other	Change in genetics	Blood sample: epigenetics and genes related to the study outcomes (single nucleotides polymorphisms (SNPs) and genome wide association studies (GWAS), NOT full genome sequencing	from baseline to week 1 and week 4, respectively
Other	Change in metabolomics related to the study outcomes	Blood sample	from baseline to week 1 and week 4, respectively
Other	Change in proteomics related to the study outcomes	Blood sample	from baseline to week 1 and week 4, respectively
Primary	Change in IGF-I between study arms	Blood sample	from baseline to week 4
Secondary	Change in IGF-1 within study arms	Blood sample	from baseline to week 4
Secondary	Change in IGF-1 between and within study arms	Blood sample	from baseline to week 1
Secondary	Change in IGFBP-3 between and within study arms	Blood sample	from baseline to week 1 and week 4, respectively
Secondary	Change in the ratio IGF-1/IGFBP-3 between and within study arms	Blood sample. Concentration of IGF-1 divided by the concentration of IGFBP-3.	from baseline to week 1 and week 4, respectively
Secondary	Change in insulin between and within study arms	Blood sample	from baseline to week 1 and week 4, respectively
Secondary	Change in relative insulin resistance between and within study arms	Blood sample	from baseline to week 1 and week 4, respectively
Secondary	Change in beta cell function between and within study arms	Blood sample	from baseline to week 1 and week 4, respectively
Secondary	Change in beta cell function/insulin resistance between and within study arms	Blood sample. Beta cell function divided by insulin resistance.	from baseline to week 1 and week 4, respectively